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510(k) Data Aggregation
(265 days)
a) ED-S100TP, ED-S100XP
This product has been designed for endoscopy and endoscopic surgery within the duodenum.
b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.
a) ED-S100TP/ED-S100XP
This product is a medical electronic side viewing endoscope for duodenum, and it is inserted into the lumen, coelom, body cavity, or inside of the body, which provides images for observation, diagnosis, photographing, or treatment. The device is used for observation, diagnosis and treatment of the duodenum, in medical institutions under the supervision of a physician. The device is equipped with bending part which enables to move the distal end part in 4 different directions such as up and down, right and left. The device consists of a flexible tube with the bending part, and the operating part with the lever to operate the bending part. The tube inside of the flexible tube is installed from the operating part to the distal end part. Inserting treatment tools into the conduit line (referred as 'forceps channel') enables trans-endoscopic treatment.
This product is a sterile single-use device and is not intended for reprocessing.
b) VS-1000
This product has image processing, light source control, AE (shutter) control functions, a connector for endoscopes, and a connector for display units, and provides images for observation, diagnosis, photography, or treatment in body cavities by connecting the display unit and endoscope.
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